Collaborative Tinnitus Research at Washington University

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St. Louis,
Missouri63110

Purpose:

The goal of this trial to see if repetitive transcranial magnetic stimulation (rTMS) to the
hearing area of the brain can lessen the perception of tinnitus. rTMS uses a strong magnet
and when placed against the scalp generates a small electrical field within the brain.
Depending on the frequency of the stimulation, this electrical field can either decrease or
increase the electrical excitability of the brain. In this study, low-frequency stimulation
will be used, which is thought to decrease nerve activity. It is this electrical
excitability of the brain that is thought to be responsible for tinnitus.
The hypothesis of this study is that rTMS can decrease the perception of tinnitus.

Study summary:

This will be a cross-over randomized trial. The order of the treatments received will be
randomly selected and the participant will not be told which treatment they are receiving.
Subjects will fall into one of the four treatment groups described below:
1. 2 weeks of active rTMS treatment followed by washout and then by 2 weeks sham
2. 2 weeks of sham followed by washout and then 2 weeks of active rTMS treatment
3. 4 weeks of active rTMS treatment followed by washout and then 4 weeks of sham
4. 4 weeks of sham followed by washout and then 4 weeks of active rTMS treatment
For the washout period between the two interventions, we will plan a minimum of 2 weeks to
avoid the problem of carryover effects. Prior to starting the next intervention after the
washout period, we will re-assess subject's tinnitus severity. To ensure no carryover
effect, the washout period will be extended for those subjects whose tinnitus severity, as
defined by the THI, is more than 20 points different than their baseline THI score.

Criteria:

On-line eligibility screening:
https://tinnitus.wustl.edu/
Inclusion Criteria:
- Men and women between the ages of 18 and 60 years.
- Subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or
greater.
- Tinnitus Handicap Inventory (THI) score of 38 or greater.
- Subjects of child-bearing potential using an appropriate form of birth control
acceptable to the research team and with a negative urine pregnancy test or undergone
sterilization procedure.
- Able to give informed consent.
- Available for once daily therapy, during working hours, Mon.-Fri.
- English-speaking.
Exclusion Criteria:
- Patients experiencing tinnitus related to cochlear implantation, retrocochlear
lesion, or other known anatomic/structural lesions of the ear and temporal bone.
- Patients with hyperacusis or misophonia (hyper-sensitivity to loud noises).
- History of seizures, history of loss of consciousness requiring medical care, any
other CNS pathology that increases a subject's risk for treatment with rTMS.
- Patients with cardiac pacemakers, intracardiac lines, implanted medication pumps,
implanted electrodes in the brain, other intracranial metal objects with the
exception of dental fillings, or any other contraindication for MRI scan.
- Any contraindication for receiving FDG PET, as determined by established clinical
criteria.
- Patients with an acute or chronic unstable medical condition which, in the opinion of
the investigator, would require stabilization prior to initiation of magnetic
stimulation.
- Patients with any active ear disease that, in the opinion of the PI, needs to be
further evaluated.
- Patients with symptoms of depression as evidenced by a score of 14 or greater on the
Beck Depression Inventory or, in the opinion of the psychiatric sub-investigator
demonstrates active mood symptoms that meet DSM-IV-TR criteria for Major Depressive
Disorder.
- Any psychiatric co-morbidity that, in the opinion of the psychiatric
sub-investigator, may complicate the interpretation of study results.
- Pregnancy
- Currently breast-feeding
- Previous treatment with rTMS
- Patients with tinnitus related to Workman's Compensation claim or litigation-related
event.
- Patients with a history of diabetes.
- Fasting glucose > 150mg/Dl.
- Patients taking any medication(s), in the opinion of the investigator, that is(are)
deemed to be etiologically related to the development of tinnitus.
- Unable to elicit a motor threshold with rTMS.
- A Mini-Mental Status Exam score less than 27.
- Untreated or newly diagnosed hypertension, (systolic blood pressures above 140 mm or
diastolic pressure above 90 mm).
- Patients with a history of claustrophobia.
- Inability to lay flat for 2 hours.
- Active alcohol and/or drug dependence or history of alcohol and/or ETOH dependence
within the last year.
- Any medical condition that, in the opinion of the investigators, confounds study
results or places the subject at greater risk.
- Unable to provide informed consent.
- Any exclusions from radiology screening for MRI or PET scanning.

NCT ID:

NCT00567892

Primary Contact:

Principal InvestigatorJay F Piccirillo, MD, CPIWashington University School of Medicine

Backup Contact:

N/A

Location Contact:

St. Louis, Missouri 63110United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

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